# EUR-Lex - 52013PC0039 - EN

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# 52013PC0039

**Proposal for a COUNCIL DECISION on submitting 4-methylamphetamine to control measures /* COM/2013/039 final - 2013/0021 (NLE) */**

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EXPLANATORY MEMORANDUM

The Council Decision 2005/387/JHA[1] on the information exchange,
risk-assessment and control of new psychoactive substances provides for a
three-step procedure that may lead to submission of a new psychoactive
substance to control measures in the Union.

On 24 September 2012 and pursuant to Article
6 of the above-mentioned Council Decision, the Council formally requested a
risk assessment on the psychoactive substance 4-methylamphetamine, to be
carried out by the extended Scientific Committee of the European Monitoring
Centre for Drugs and Drug Addiction (EMCDDA).

The main results of the risk assessment are
the following:

(1)
4-methylamphetamine is a synthetic
ring-methylated derivative of the controlled substance amphetamine which provokes
physical effects that can be compared to those produced by other stimulant substances
such as amphetamine.

(2)
Acute health problems and adverse effects
related to the use of 4-methylamphetamine can occur and have been documented. The
patterns of use appear to follow those associated with amphetamine.

(3)
Between 2010 and 2012, 21 fatalities in four
Member States have been reported where 4-methylamphetamine alone or in combination
with other substances has been detected in post-mortem samples. In some cases 4-methylamphetamine
was the predominant drug detected.

(4)
4-methylamphetamine has no known, established or
acknowledged medical value or use. However, it is used as an analytical
reference standard and in scientific research.

Pursuant to Article 8(1) of the Council
Decision, within six weeks from the date on which it receives the Risk
Assessment Report, the Commission shall either present to the Council an
initiative to have the new psychoactive substance subjected to control
measures, or shall present a report justifying why it deems it not necessary to
present such an initiative.

Although the scientific evidence concerning
the overall risks and patterns of use of 4-methylamphetamine is still limited
at this stage, there are grounds for subjecting the substance to control across
the Union. The main reason is that, according to the available information from
the Risk Assessment Report, the substance poses risks to health, as highlighted
above. These risks are heightened by the fact that 4-methylamphetamine is often
sold as amphetamine or in combination with amphetamine or other substances, and
that most users are unaware that they are consuming this specific substance.

Furthermore, taking into account that organised
crime appears to be involved in the manufacture, trafficking and supply of
4-methylamphetamine and given the similarity of this substance with amphetamine,
the possibility that 4-methylamphetamine develops as an alternative to amphetamine
further justifies subjecting the substance to control measures.

The objective of this proposal for a
Council Decision is to call upon Member States to submit 4-methylamphetamine to
control measures and criminal penalties as provided under their legislation by
virtue of their obligations under the 1971 United Nations Convention on
Psychotropic Substances.

2013/0021 (NLE)

Proposal for a

COUNCIL DECISION

on submitting 4-methylamphetamine to
control measures

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the
Functioning of the European Union,

Having regard to the Council Decision
2005/387/JHA of 10 May 2005 on the information exchange, risk-assessment and
control of new psychoactive substances[2],
and in particular Article 8 (3) thereof,

Having regard to the initiative of the
Commission,

Whereas:

(1)
A Risk Assessment Report on 4-methylamphetamine was
drawn up on the basis of Article 6 of Decision 2005/387/JHA by a special
session of the extended Scientific Committee of the European Monitoring Centre
for Drugs and Drug Addiction, and was subsequently received by the Commission
on 29 November 2012.

(2)
4-methylamphetamine is a synthetic ring-methylated
derivative of amphetamine which has predominantly been seized in powder and
paste form in samples containing amphetamine and caffeine, but which has also
appeared in tablet and liquid form. It has emerged on the illicit amphetamine
market where it is sold and used as amphetamine. There has been one report of
the substance being detected in a commercial product sold on the internet. The
main chemical precursor for the synthesis of 4-methylamphetamine is
4-methylbenzyl methyl ketone (4-methyl-BMK), which appears to be commercially
available on the internet and is not controlled under the 1988 United Nations
Convention against Illicit Traffic in Narcotic Drugs and Psychotropic
Substances.

(3)
4-methylamphetamine's specific physical effects have
been rarely reported by users as they are typically unaware that they have
taken the substance. However, the few reports that are available suggest that
it has stimulant-type effects. Limited available data related to humans suggest
that the adverse effects of 4-methylamphetamine include hyperthermia,
hypertension, anorexia, nausea, perspiration, gastric distress, coughing,
vomiting, headache, palpitations, insomnia, paranoia, anxiety and depression. Current
data is not sufficient to determine the relative dependence-producing potential
of this substance.

(4)
The acute toxicity of 4-methylamphetamine is
similar to that of other stimulants, according to the limited data sources
available. Certain evidence suggests that in combination with other substances,
including amphetamine and caffeine, there may be a higher risk of overall
enhanced toxicity.

(5)
There have been a total of 21 fatalities
registered in four Member States where 4-methylamphetamine alone or in
combination with one or more substances, especially amphetamine, has been
detected in post-mortem samples. While it is not possible to determine with
certainty the role of 4-methylamphetamine in these fatalities from the
available information, in some cases the substance was the predominant drug
detected, with levels comparable to those found in certain cases of death
caused by the consumption of amphetamine.

(6)
4-methylamphetamine has been detected in 15
Member States, while one Member State has reported the manufacture of the
substance on its territory. Prevalence specific to 4-methylamphetamine is
difficult to estimate. There is no information on specific demand for the
substance from user groups. It is not commercially marketed through internet
shops.

(7)
The available information suggests that it is
produced and distributed by the same organised crime groups that are involved in
the manufacture and trafficking of the controlled drug amphetamine.

(8)
4-methylamphetamine has no known, established or
acknowledged medical value or use in the Union and there is no marketing
authorisation for the substance in the Union. Apart from its use as an
analytical reference standard and in scientific research, there are no
indications that it may be used for any other legitimate purpose.

(9)
4-methylamphetamine is currently not under
assessment and has not been under assessment by the United Nations system. Eight
Member States control the substance under drug control legislation by virtue of
their obligations under the 1971 United Nations Convention on Psychotropic
Substances. Two other Member States apply the generic definition in their
national legislation to the product while one Member State controls it under
its medicines legislation.

(10)
Although the Risk Assessment Report reveals that
limited scientific evidence is available on the characteristics and risks of
4-methylamphetamine and points out that further studies are required on the
overall health and social risks associated with the substance, the available
evidence provides sufficient grounds for subjecting the substance to control
measures across the Union. This is because of the health risks that the
substance poses, as documented in its detection in several cases of fatalities,
especially when used in combination with other substances, because of its strong
resemblance in terms of appearance and effects with amphetamine and the fact
that users may unknowingly consume this substance. These risks as well as the
limited medical value or use of 4-methylamphetamine, justify a decision to subject
it to control measures across the Union.

(11)
Since ten Member States already control 4-methylamphetamine,
placing it under control across the Union may help avoid problems in
cross-border law enforcement and judicial cooperation.

(12)
Union-wide control measures may help prevent
4-methylamphetamine developing as an alternative to amphetamine in the illicit
drug markets,

HAS
ADOPTED THIS DECISION:

Article 1

The new psychoactive substance
4-methylamphetamine is hereby submitted to control measures.

Article 2

Member States shall take the necessary
measures, in accordance with their national law, and not later than one year
from the date this decision is published, to submit 4-methylamphetamine to
control measures and criminal penalties as provided for under their legislation
by virtue of their obligations under the 1971 United Nations Convention on
Psychotropic Substances.

Article 3

This Decision shall enter into force on the
day following that of its publication in the Official Journal of the
European Union.

Done at Brussels,

For
the Council

The
President

[1]               OJ L 127, 20.5.2005, p. 32.

[2]               OJ
L 127, 20.5.2005, p. 32.